Posts Tagged ‘ethical’

Imagine a world where medical devices such as pacemakers could be implanted into the body, without the need for traditional batteries and cables and powered simply by body fluids. Well, it might not be as far away as you think. There have been some exciting and fascinating developments recently. Researchers have started to utilise a unique property of some materials, known as piezoelectricity, to generate electricity from kinetic energy….the same technology that is used in ‘wind-up torches’ to convert kinetic energy to electricity. Read more about this fascinating topic by following this link.

We are proud to announce an updated and improved one day intensive trainingcourse on pharma packaging!

Pharmaceutical packaging is a very specialised area with its own unique issues and problems. This introductory course will provide delegates with a good basic grounding and appreciation of what is required for the packaging of pharmaceutical and healthcare products – both Prescription Only Medicines (POM) and Over The Counter (OTC) and will have relevance in other affiliated areas such as Veterinary and, to some extent, Medical Devices too.

Whether you know nothing or have a basic understanding, this course will provide you with useful knowledge and insights from experts who have worked in the industry for over 25 years.

For more information – Follow this link to our Training Page to download a PDF flyer

With an ageing population and the growth of emerging economies across the world, the pharmaceutical sector is booming. Research business IMS predicts that the global pharmaceutical industry will reach sales of as much as $1.2tn by 2017 – representing annual growth of 3%-6% and, crucially, a growing market for pharmaceutical packaging suppliers and contract packers.

Yet it is a market that brings particular challenges, and particular opportunities, to those packaging suppliers and packers operating within it, not least the regulatory environment, which is complex and becoming more so. New regulations – notably the EU Falsified Medicines Directive, which requires every individual pack to carry a unique serial number – are posing new challenges to the supply chain both for product and packaging.

Chris Penfold, CEO of Design Cognition, along with a number of other industry experts recently took part in a Packaging News and Essentra roundtable discussion looking at the wide range of issues facing players in the pharmaceutical packaging segment.

The Tween market is one of the most desirable and fastest growing consumer groups and said to be worth over $200-billion-per-year. Aimed at 9 to 14 years old, it is a sensitive market with many dichotomies. Where girls are said to be “too old for toys, too young for boys,” and boys…are just boys…never too old for toys . Tweens are feisty, opinionated, razor-sharp, brutally honest, slightly awkward, and very, very important for your brand.

U by Kotex - Tween packaging design

Much work has been going on recently to explore this area and the following article provides some useful and interesting insights into how best to differentiate your packaging to appeal to this particular audience, who:

1. Aspire to be older, but are still children.
2. Want to be unique, but also still fit in.
3. Have strong ideas about what they want to buy, but need parental involvement and approval to purchase those things.

But, whilst also being mindful of the underlying needs of their parents who still have a big ‘hand’ in what they buy. Some great examples are demonstrated by U by Kotex Tween and Geo Girl, Walmart’s new line of Eco-friendly cosmetics for 8 to 12 year olds (which personally I feel a little less comfortable with)…..but read on and let us know what you think…..

Here’s how ‘Eco Warrior’ and ‘Gaia Capitalist’ David de Rothschild made his catamaran ‘Plastiki’ out of recycled PET bottle packaging -- turning waste into resource and into an (almost) completely recyclable boat, that he then sailed from San Francisco to Sydney.

As we have discussed in previous posts, there is a huge and ever-increasing mountain of rubbish growing in the middle of the Pacific, like a giant festering ’soup’, much of which consists of plastic packaging waste. This has had a massive knock-on affect in the form of polluted beaches on islands throughout the South Pacific. See our previous article: Great Pacific Garbage Patch article

David de Rothschild is a man on a mission. The offspring of the wealthy banking family, he is one of a new breed of environmental crusaders and entrepreneurs that some are calling ‘Gaia capitalists’. ‘Gaia’ in mythology was the primal Greek goddess of the Earth and aptly a ‘gyre’ in oceanography is any large system of rotating ocean currents (source: Wikipedia).

To highlight the Pacific issue and raise it’s profile in mainstream media, De Rothschild decided to use his family’s high profile (& money) to build a yacht made entirely of recycled plastic bottle packaging, which he named ‘Plastiki’ (making reference and tribute to the late Thor Heyerdahl’s papyrus Kon-tiki raft which crossed the Pacific back in 1947). Over a four month period he sailed this 60ft catamaran from San Francisco to Sydney, where he landed last week. But his exploits are no shallow ploy to fill aimless days with fun and adventure.

De Rothschild and his ‘Gaia’ friends are driven by a combination of social conscience and economic pragmatism, seeking a ‘paradigm shift’ in the way we live and desecrate our planet. They espouse a new form of capitalism that factors in the environment and social wellbeing as a cost. It considers protecting the environment not only as a moral issue but as a set of design challenges to correct inefficiencies that make the capitalist system unsustainable. Waste, for example, is considered the result of inadequate thinking. If you are smarter about it, and create products that work properly, then you shouldn’t have to throw anything away at the end – should you? The group include Chad Hurley (33) who with his co-founder, sold YouTube to Google for $1.6Bn and has since ploughed some of his fortune into the Green Products Innovation Institute and Jeffrey Skoll, worth $2.4Bn, who wrote the business plan for eBay and has set up the Skoll Foundation to encourage ’social entrepreneurs’ to play a greater role in developing a better world (source: The Sunday Times).

These are ‘game changers’, who see solutions where others see problems – a new entrepreneurial revolution – one of collaboration something that de Rothschild calls ‘Planet 2.0′. So I feel that we will be hearing a lot more from this ‘band of brothers’ in the future. They mean to ‘rattle some cages’, get us all to think differently and make a real impact by influencing things at ‘the top’. They have a point! Can we really carry on the way we are? For a really ’sustainable future’, for our children and their children’s sakes, things have to change a lot quicker.What do you think?

Traditionally medical products, devices and their related packaging has been ’sidelined’ in much of the debate around the environment, where the major focus has been on retail products. However, it is estimated (Mulligan) that medical packaging contributes between 30% to 50% (or more) of the medical waste stream. There is a lot of work going on in the background, within the National Health Service (NHS) in the UK, and further afield globally, as healthcare practitioners are put under increasing pressure to ‘go green’, become more ’sustainable’ and reduce their ‘carbon footprint’. These initiatives go right to the core of their infrastructure, looking at everything from operating theatre furniture and equipment, through to medical devices and all related packaging.

However, there are wider ramifications, as it apparent that these sustainability initiatives will also enable huge cost benefits, improved regulatory compliance, and enhanced corporate social responsibility (CSR) when done correctly. So no pressure then !

On the face of it, this looks like a huge and daunting task, but with the aid of modern modelling techniques, such as those used by Walmart and by Marks & Spencer (M&S) in their ‘Plan A’, data and issues can be quite easily ‘chunked-down’ into manageable bite-size segments. This can help prioritisation and enable ‘quick wins’ on the highest ‘value creating’ initiatives.

It is important that suppliers and medical device manufacturers think about these sweeping changes and, if not already doing so, start to design and develop medical devices & healthcare packaging to meet these more stringent requirements. Next-generation packaging must be: 1) easy to manufacture; 2) meet stringent regulatory requirements; 3) meet the needs of distributors, healthcare institutions, and medical practitioners; and 4) minimize impact on the environment.

The following article is one that I’ve recently written for the Packaging Professional magazine, which details a fascinating 25 year transformation in the way we work and do business in the pharmaceutical packaging industry. Over that period the industry itself has undergone huge change and with recent economic pressures and the rise of generic competition is likely to continue unabated.

Back in the 1980’s, before the days of email and the internet, working in packaging could sometimes be a lonely business, especially in an area like pharmaceuticals where regulatory requirements, standards and process were constantly being updated as authorities, such as the US Food and Drug Administration (FDA) and the UK Medicines Control Agency (MCA), evolved increasing powers and rules. A situation where ‘fit for purpose’ packaging could be a matter of life and death.

Pharma companies are strictly regulated and need to work to tight and common standards and most companies were running similar, machinery, quality systems and packaging materials. So learnings from one company could greatly help another and save having to ‘reinvent the wheel’. It was also important for the industry to provide a collective view to positively influence proposed legislation and regulations, with a common and pragmatic ‘voice’.

So back in 1984, the ‘seed’ of an idea for a group was ‘sown’ by Alan Haskins of Roussel Laboratories and Roy Gray of ICI Pharmaceuticals, after Roy’s boss had visited the USA and seen a successful American group working in the same sector. This was a defining moment and the group would not have happened without their collective vision and proactive approach. The first Pharmaceutical Common Interest Group (PCIG) meeting took place on 16th October 1984 at Sysonby Lodge, which was the head office of The Institute of Packaging (IOP) at the time). The meeting was chaired by Alan Haskins, with Roy Gray as Secretary and an attendance of 18 people from 15 pharmaceutical companies from across the industry. There were 37 questions raised & discussed at that meeting on a range of topics, including: a New British Standard for aluminium flexible tubes, label adhesives, Tamper Evidence and EAN bar codes – themes that would arise again and again over the years.

It was agreed that there would be three meetings per year and venues would rotate across the various company sites, but over the years most were actually hosted by the IOP.

One of the original members, Mike Shorten, who worked for Boots Pharmaceuticals at the time and is now retired, recalls:

“The PCIG soon became my most important network. Forty pharmaceutical practitioners across all sectors of the industry provided a powerful resource that could offer practical experience about most issues and without any consultants’ fees! A great strength of the group was the willingness of its members to talk openly about issues and share best practice and then to collectively influence new regulations and standards”

How the CIG has changed over the years

I have myself have been a member of the group for over 18 years (since 1991) and over that time can recall a great deal of camaraderie, focused help for each other and pragmatism having helped us all deal with issues as diverse as use of high barrier blister materials, bar coding issues and leeching of preservative through polyethylene bottles.

As issues became apparent, some common themes evolved and a number of dedicated ‘sub groups’ were set up to focus on specific topics. Four of these were Working Groups for Digital Artwork & Reprographics (DAR), Validation, Child Resistance and Quality Standards. The DAR subgroup was set up at a time when ‘desktop publishing’ was a buzz word being used as artwork generation moved from ‘old fashioned’ layout board, to a digitised computerised system. At the time there was no common standard. There was a range of hardware (PC & Mac based), a number of operating systems, and various artwork creative software packages on each platform. The ease by which artwork could be generated and manipulated raised its own issues in terms of artwork version control and (in the early days) data going ‘missing’ sometimes between approval and print – which had the potential to cause a catastrophic result. So the group played a critical role in sharing ‘best practice’ and setting appropriate standards.

The Validation subgroup was formed in 1992, the founding Chairman being Mike Harwood of The Wellcome Foundation, Dartford. A subsequent Chairman (1993-98) John Cooper (of Pfizer at the time) recalls “The original intent was to develop a set of guidelines for validating pharmaceutical packaging equipment and then issue to IOP members, but as the guideline developed and the information was shared informally with machine manufacturers it became obvious that it would be of a wider benefit to publish a ‘book’. As I was a member both of the PCIG and Institute of Quality Assurance Pharma Quality Group (IQA PQG), I suggested that this was published jointly as a monograph in the series which was already established by the PQG. The monograph was published in 1998 and launched at a joint meeting of PCIG and PQG at the Royal Pharmaceutical Society in Lambeth with over 200 people in attendance, including the MCA Head of Inspection and Enforcement, Gordon Munro!” That was another defining moment in the ‘life’ of the PCIG and evidence of the esteem with which the group was held within the pharmaceutical industry. The third edition of that monograph is presently due for print.

It was not uncommon in the early days for PCIG meeting attendance to be around 35-40 people, with standing room only. Questions would be collated by the Secretary and shared at each meeting. It would sometimes take 3 or 4 hours to go through them all, one-by-one. As the years have gone by and we have moved in to a digital age, email has enabled members to converse more easily and questions can be asked and answered sometimes within minutes. So the focus and frequency of face-to-face meetings changed to providing more of an opportunity for discussing in more depth, processes, procedures, technology and impending legislation, and to keep in touch with old colleagues and friends. Together with the myriad of mergers among the pharma companies, this has meant attendances have dropped.

Where we are going with it in future
The PCIG (now called the Pharmaceutical Packaging Forum – PPF) is still active, with a core of ‘stalwart’ members and a new voluntary Secretary, David Pethick, former Director of Packaging Development at GSK. David is upbeat about future for the group and says “the pharma landscape, increasing demands and changing regulations on packaging present as much, if not more of, a challenge as when the PCIG was first established. I see both a need and role for a vibrant PCIG to help the pharma packaging professional meet those challenges, whether that be from simply providing networking among its members, to wider influencing, technical leadership, training needs or whatever”.

Pharma packaging legislation/regulation has changed enormously, and the Society recently received an enquiry about training courses on this. Feedback from PCIG members showed a high level of similar interest. Whether or not such a course could be developed is still a work in progress, but both David (for PPF) and Ian Morris, Training Manager at IOM3, would be interested in readers’ feedback.

Ultimately, the future and utility of PCIG, as over its past history, is reliant on the members who actively value and contribute to it.

Chris Penfold

If you work in Pharma and are interested in knowing more or in joining the PPF group, you can contact David Pethick (the Secretary) at dppk@btinternet .

On my own part (Chris), as well as continuing to be an active member of the PPF and a consultant, I am also the External Relations Officer of the East Midlands Packaging Society, for which you can find more information at: East Midlands Packaging Society.

You can find more help and advice on various aspects of pharmaceutical packaging at our sister site: The Pharma Gateway

In order to help you develop your packaging more productively, we have generated a series of FREE short 1-2 minute videos detailing our Tip Ten Tips for getting it right. We will be posting 1 x video per day on this blog site over a 10 day period – so keep a look out for them – they could save you a £££$$$ fortune in the long run!

DAY 6 – Tip No6: These days the environment is top of everybody’s mind. But, did you know, there is lots of legislation to which you must comply? Also, as new materials continually come on to the market it’s difficult to keep up with it all…find out more in the video…

A recent Los Angeles Times article examines how an increase in counterfeit condoms in China has health officials fearing the worst — the products “may in fact spread infectious diseases, tarnishing the axiom that condoms mean safe sex.”

The newspaper continues, “Authorities estimate that up to a third of the contraceptives used in some parts of China are counterfeits, despite improvements in state food and drug oversight. None of the counterfeits are properly sterilized, and others are of such inferior quality that they could rupture during use.”

The article details how authorities are attempting to track down what they estimate are more than one million condoms distributed throughout China, and notes how the knock-off condoms were uncovered in discount stores in New York, Texas and Virginia in 2008.